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Establish the Implementation project
Project Plan
Project Resources
Conduct ISO 13485 Awareness Training
Identify Implementation Team
Conduct ISO 13485 Implementation Training
Define ISO 13485 Context
Define ISO 13485 Scope
Define ISO 13485 Policy
Define ISO 13485 RA & RT
Implement ISO 13485 Operational Controls
Conduct ISO 13485 Pre-assessment Audit
Define ISO 13485 Objectives
Conduct ISO 13485 Internal Auditor Training
Close the Gaps and Proceed for Certification Audit
Define ISO 13485 Documented Information
Conduct Internal Audits, Closures, Management reviews
Monitoring, Measurement and Performance Evaluation
Communication with Interested Parties
Obtain Top Management’s Committment